Imalek (Imatinib Mesylate Tablets)

Imalek Tablets
© Clearsky Pharmacy
Imalek (Imatinib Mesylate Tablets) is used to treat
certain types of cancer (such as acute
lymphoblastic leukemia, chronic myeloid leukemia,
gastrointestinal stromal tumors, and
myelodysplastic/myeloproliferative diseases) and
blood problems.

Imalek Tablets
Imalek Tablets are manufactured by
Sun Pharmaceutical Industries Limited,
India.
(Website: www.sunpharma.com)

Imatinib Mesylate Tablets – Brand Names
Imatinib Mesylate tablets are available
as Gleevec, Imalek, Veenat, Imatib,
Celonib, Glivec, Lupinib, Mesylonib,
Mitinab, Imatinib, Shantinib, Unitinib,
Levin and Imanib.

Active Ingredient
The active ingredient contained in Imalek
tablets is Imatinib Mesylate. Each Imalek
tablet contains 100 mg or 400 mg of Imatinib
Mesylate.

Chemical Structure
The structure of Imatinib Mesylate is given
below:

Uses of Imalek Tablets
Imalek tablets are used to treat newly Diagnosed
Philadelphia Positive Chronic Myeloid Leukemia (Ph+
CML), Ph+ CML in Blast Crisis (BC), Accelerated Phase
(AP) or Chronic Phase (CP) After Interferon-alpha (IFN)
Therapy, Adult patients with Ph+ Acute Lymphoblastic
Leukemia (ALL), Adult patients with relapsed or refractory
Ph+ ALL as monotherapy,
Myelodysplastic/Myeloproliferative Diseases (MDS/MPD),
adult patients with myelodysplastic / myeloproliferative
diseases (MDS/MPD) associated with platelet-derived
growth factor receptor (PDGFR) gene re-arrangements.
Aggressive Systemic Mastocytosis (ASM),
Hypereosinophilic Syndrome (HES) and/or Chronic
Eosinophilic Leukemia (CEL) and Dermatofibrosarcoma
Protuberans (DFSP).

Uses of Imalek Tablets
Imalek tablets are also used in the treatment
of adult patients with systemic mastocytosis
(SM) without the D816V c-KIT mutation or
with c-Kit mutational status unknown, and
adjuvant treatment of adult patients following
resection of KIT+GIST.

Imalek Dosage
➢Adult Patients with Ph+ CML CP, AP, or BC : The
recommended dose of Generic Imatinib tablets is
400 mg/day for adult patients in chronic phase CML
and 600 mg/day for adult patients in accelerated
phase or blast crisis.
The dosage of Imalek tablets (Generic Imatinib
Mesylate) is given below. The prescribed dose must
be administered orally, along with a meal and a large
glass of water. Doses of 400 mg or 600 mg must be
administered once daily, whereas a dose of 800 mg
should be administered as 400 mg twice a day. Imalek
tablets should not be crushed.

Generic Imatinib Tablets - Dosage
➢Adult Patients with Ph+ ALL: The recommended dose
of imatinib mesylate tablets is 600 mg/day for adult
patients with relapsed/refractory Ph+ ALL.
➢ Adult Patients with MDS/MPD: Determine PDGFRb
gene rearrangements status prior to initiating treatment.
The recommended dose of Imalek tablets is 400
mg/day for adult patients with MDS/MPD.
➢Adult Patients with ASM: Determine D816V c-Kit
mutation status prior to initiating treatment. The
recommended dose of Imalek tablets is 400 mg/day for
adult patients with ASM without the D816V c-Kit
mutation.
The dosage of Generic Imatinib Mesylate (Imalek
Tablets) is given below:

Imalek Tablets - Dosage
➢Adult Patients with DFSP: The recommended dose
of Generic Imatinib Mesylate tablets (Imalek) is 800
mg/day for adult patients with DFSP.
➢Adult Patients with HES/CEL: The recommended
dose of Imalek (Imatinib Mesylate tablets) is 400
mg/day for adult patients with HES/CEL.
The dosage of Generic Imatinib Mesylate (Imalek
Tablets) is given below:

Storage Instructions
Generic Imatinib Mesylate (Imalek
tablets ) have to be stored at controlled
room temperature i.e. 25°C (77°F)
with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

Imalek Tablets Warnings
Edema and severe fluid retention have occurred in
patients undergoing treatment with Imatinib Mesylate
tablets. Weigh patients regularly and manage
unexpected rapid weight gain by drug interruption and
diuretics.
Cytopenias, particularly anemia, neutropenia, and
thrombocytopenia, have occurred.
Manage with dose reduction,dose interruption, or
discontinuation of treatment. Perform complete blood
counts weekly for the first month, biweekly for the
second month, and periodically thereafter.
Severe congestive heart failure and left ventricular
dysfunction have been reported, particularly in patients
with comorbidities and risk factors. Doctors should
monitor and treat patients with cardiac disease or risk
factors for cardiac failure.

Generic Imatinib Warnings
Severe hepatotoxicity including fatalities could
occur. Assess liver function before starting
treatment and monthly thereafter or as clinically
indicated. Monitor liver function when combined
with chemotherapy known to be associated
with liver dysfunction.
Grade 3/4 hemorrhage has been reported in
clinical studies in patients with newly diagnosed
CML and with GIST. GI tumor sites may be the
source of GI bleeds in GIST.
Gastrointestinal perforations, some fatal, have
been reported.

Cardiogenic shock/left ventricular dysfunction
has been associated with the starting of
treatment with Imalek tablets in patients with
conditions associated with high eosinophil
levels (e.g. HES, MDS/MPD and ASM).
Bullous dermatologic reactions (e.g., erythema
multiforme and Stevens-Johnson syndrome)
have been reported with the use of Imatinib
(Imalek tablets).
Hypothyroidism has been reported in
thyroidectomy patients undergoing
Levothyroxine replacement. Closely monitor
TSH levels in such patients.

Fetal harm can occur when Generic Imatinib
(Imalek) is administered to a pregnant woman.
Advise women of the potential harm to the fetus,
and to avoid pregnancy when taking Generic
Imatinib tablets.
Growth retardation occurring in children and pre-
adolescents receiving Imatinib Mesylate tablets
has been reported.
Close monitoring of growth in children under
Imalek treatment is recommended.
Tumor lysis syndrome. Close monitoring is
recommended in such patients.

Imalek Tablets Warnings
Reports of motor vehicle accidents have been
received in patients receiving Imatinib
Mesylate tablets (Imalek). Caution patients
about driving a car or operating machinery.
Renal toxicity. A decline in renal function may
occur in patients receiving Imatinib Mesylate
tablets (Imalek). Evaluate renal function at
baseline and during therapy, with attention to
risk factors for renal dysfunction.

Imalek Tablets
Contraindications
Imalek tablets are contraindicated in
patients with a hypersensitivity to
Imatinib Mesylate or any other
component of this medication.

Imatinib (Imalek Tablets) Side Effects
➢The most frequently reported side effects of Imatinib
Mesylate (Imalek Tablets) with an incidence rate equal to
or greater than 30% were edema, nausea, vomiting,
muscle cramps, musculoskeletal pain, diarrhea, rash,
fatigue and abdominal pain.
➢The following are serious side effects of this medicine:
Fluid Retention and Edema, Hematologic Toxicity,
Congestive Heart Failure and Left Ventricular Dysfunction,
Hepatotoxicity, Hemorrhage, Gastrointestinal Disorders,
Hypereosinophilic Cardiac Toxicity, Dermatologic
Toxicities, Hypothyroidism, Growth Retardation in
Children and Adolescents, Tumor Lysis Syndrome,
Impairments Related to Driving and Using Machinery and
Renal Toxicity.

Imalek Tablets Overdose
Experience with doses greater than 800 mg is
limited. The following adverse effects occurred in the
following reported cases of adult overdose of
Imatinib Mesylate Tablets.
1,200 mg –1,600 mg (duration varying between 1 to
10 days): Nausea, vomiting, diarrhoea, rash
erythema, oedema, swelling, fatigue, muscle
spasms, thrombocytopenia, pancytopenia,
abdominal pain, headache, decreased appetite.
1,800 mg –3,200 mg (as high as 3,200 mg daily for
6 days): Weakness, myalgia, increased CPK
(creatine phosphokinase), increased bilirubin, GI
pain.

Imalek Tablets Overdose
6,400 mg (single dose): One case
reported about a patient who experienced
nausea, vomiting, abdominal pain,
pyrexia, facial swelling, neutrophil count
decreased, and increased transaminases.
8 g to 10 g (single dose): Vomiting and GI
pain have been reported.

Imatinib Tablets Overdose
In the event of Imatinib Mesylate (Imalek
Tablets) overdosage, the patient must be
observed and appropriate supportive
treatment given.

Imatinib Mesylate During Pregnancy
Imatinib Mesylate (Imalek tablets) has been
classified by the US FDA as Pregnancy Category D.
Women of childbearing potential must be advised
to avoid becoming pregnant while taking Imalek
tablets. Imatinib can cause fetal harm when
administered to a pregnant woman.
Imatinib and its active metabolite are excreted into
human milk. Because of the potential for serious
adverse reactions in breastfed infants from Imatinib
Mesylate, a lactating woman must be advised not
to breastfeed during treatment and for one month
after the last dose of Imalek tablets.

Imalek Tablets
For more details on
Imalek Tablets click here
Imalek (Imatinib Mesylate tablets) by Sun
Pharmaceutical Industries Limited, India.

Imalek (Imatinib Mesylate Tablets)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Imalek (Imatinib Mesylate Tablets)

Similar to Imalek (Imatinib Mesylate Tablets) (20)

More from Clearsky Pharmacy

More from Clearsky Pharmacy (20)

Recently uploaded

Recently uploaded (20)

Imalek (Imatinib Mesylate Tablets)